Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Infertility Clinical Trial

Official title:

Protocol Evaluation for Improved In Vitro Fertilization Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00334243
• Other study ID #: Purcell-01
• Status: Terminated
• Phase: Phase 4
• First received: June 6, 2006
• Last updated: October 5, 2011
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: October 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.

Description:

Infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming IVF cycle. Each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval. Chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy). Statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Infertile patients

• Undergoing IVF

• Antral Follicle Count Less than 10

• Prior history of less than 5 oocytes generated during an IVF cycle

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Microflare protocol for IVF

• Antagonist protocol for IVF

• Demi-halt protocol for IVF

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate
Secondary	Cycle Cancellation Rates
Secondary	Number of Oocytes Generated
Secondary	Number of Embryos Generated
Secondary	Serum hormonal evaluation
Secondary	Follicular fluid evaluation